Mavericks Wanted
When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
In 2015, we pioneered a moneyball for biotech approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentationincluding the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.
What Youll Do
The Associate Director, Biostatistics & AI is a senior individual contributor and emerging people leader responsible for the delivery of high-quality statistical analyses and for designing, building, and embedding AI/ML interfaces into the day-to-day workflows of the biometrics function. This role sits at the intersection of pharmaceutical statistical science and applied AI engineering and is the primary internal resource for setting up, validating, and governing AI tooling in a GxP-compliant environment.
A successful candidate will bring either deep pharmaceutical biometrics expertise with growing AI/ML skills, or strong AI/ML engineering experience with meaningful exposure to clinical or life sciences data. In either case, they will have the drive and aptitude to rapidly bridge both domains. They will work across cross-functional teams including Clinical Development, Regulatory Affairs, Medical Affairs, and Pharmacovigilance, and will manage CRO statisticians and programmers on assigned programs.
Responsibilities
Pharmaceutical Biostatistics
Apply appropriate statistical methodologies supporting medical insights, value demonstration, safety monitoring, and lifecycle management
Contribute to statistical design, analysis, and reporting for Phase IIIV clinical trials, including adaptive designs, Bayesian methods, and estimands under ICH E9(R1)
Contribute to NDA, BLA, MAA, and other global regulatory submissions as lead or co-statistician; support responses to health authority queries
Stay current with FDA, EMA, and ICH guidance on statistical methodology, and real-world evidence (RWE)
AI Interface Setup & Implementation
Design and implement AI/ML interface environments connecting biometric platforms (SAS, R, Python) with enterprise LLM APIs, RAG pipelines, and clinical data repositories
Build, test, and iterate on AI-powered tools for SAP drafting, TFL automation, anomaly detection, protocol deviation identification, and regulatory document support
Establish and maintain MLOps pipelines for model development, validation, deployment, and monitoring within a GxP-compliant, audit-ready framework
Implement AI governance standards including explainability (SHAP/XAI), bias assessment, and 21 CFR Part 11 / EU Annex 11 compliant documentation
Evaluate and deploy AI-powered automation for CDISC mapping, data cleaning, and submission package preparation
Partner with IT and third-party vendors to integrate AI tools with EDC, CTMS, RTSM, and pharmacovigilance systems
Cross-Functional Collaboration & CRO Oversight
Translate statistical and AI concepts into clear, actionable insights for medical, regulatory, and commercial stakeholders
Partner with Clinical Development, Regulatory Affairs, Medical Affairs, and Pharmacovigilance to align biometrics and AI deliverables with program timelines
Develop and maintain SOPs, work instructions, and best practices for biostatistics, AI tooling, and statistical programming
Where Youll Work
This is a U.S.-based remote role. Quarterly visits to our [City, State] office, or as needed based on program requirements.
Who You Are
PhD or Masters degree in Biostatistics, Statistics, Computer Science, Artificial Intelligence, Data Science, or a closely related quantitative field
We recognize that strong candidates may come from different professional paths. We welcome applications from either of the following profiles:
Track A Biostats-First with Applied AI Skills
5+ years (PhD) or 7+ years (Masters) of pharmaceutical biostatistics experience in drug development, biotech, or CRO settings
Expert-level proficiency in SAS and/or R; working knowledge of Python for data science or scripting
Demonstrated exposure to AI/ML tools such as LLM APIs, prompt engineering, or automation scripting with a strong interest in expanding these capabilities in a GxP environment
Deep knowledge of CDISC standards (SDTM, ADaM, Define-XML) and regulatory submission workflows; experience contributing to NDA/BLA/MAA preferred
Track B AI/ML-First with Pharma/Biostats Exposure
3+ years of hands-on AI/ML engineering experience, including building and deploying LLM-powered tools, RAG pipelines (LangChain or equivalent), agentic workflows, and/or MLOps infrastructure
Strong Python proficiency for AI/ML development; working familiarity with SAS and/or R in a statistical or data science context
Meaningful exposure to clinical or life sciences data e.g., working with clinical trial datasets, CDISC standards, pharmacovigilance data, or regulated environments (GxP/21 CFR Part 11) with eagerness to deepen this domain expertise
Foundational understanding of statistical concepts (e.g., hypothesis testing, regression, survival analysis) relevant to clinical development
All Candidates
Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments (FDA, EMA, ICH)
Excellent written and verbal communication skills, with the ability to engage both technical and non-technical audiences
Ability to work as part of a cross-functional team in a fast-paced environment and collaborate effectively with external partners and vendors
You demonstrate genuine curiosity and initiative in building and deploying AI-powered tools not just adopting them
Rewarding Those Who Make the Mission Possible
We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
Financial Benefits
Health & Wellbeing
Skill Development & Career Paths
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
Salary
$173,800-$217,000 USD
As a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
For USA based roles:
Financial & Rewards
Health & Well-Being
Skill Development & Career Paths: